U.S. patent application number 14/322445 was filed with the patent office on 2016-01-07 for system and method for obtaining electronic consent.
The applicant listed for this patent is Don B. Lee. Invention is credited to Don B. Lee.
Application Number | 20160006715 14/322445 |
Document ID | / |
Family ID | 55017837 |
Filed Date | 2016-01-07 |
United States Patent
Application |
20160006715 |
Kind Code |
A1 |
Lee; Don B. |
January 7, 2016 |
SYSTEM AND METHOD FOR OBTAINING ELECTRONIC CONSENT
Abstract
A system for obtaining electronic consent whereby a user
provides consent through a mobile device. In the system the mobile
device is electronically connected to a central computing system.
The central computing system generates the consent forms that are
transmitted over the communication link to the mobile device. After
inputting a unique password, the user is then able to review and
attest to the documents provided on the mobile device. Upon
completion, the documents are then transmitted back to the central
computing device where they are reviewed for completeness and
accuracy. The authorized documents are then filed in a secure
electronic file. The mobile device is then purged of all personal
data in order to maintain the integrity of the personal
information.
Inventors: |
Lee; Don B.; (New York,
NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Lee; Don B. |
New York |
NY |
US |
|
|
Family ID: |
55017837 |
Appl. No.: |
14/322445 |
Filed: |
July 2, 2014 |
Current U.S.
Class: |
713/155 |
Current CPC
Class: |
H04W 12/0804 20190101;
G16H 10/60 20180101; G06Q 10/10 20130101; H04L 63/083 20130101 |
International
Class: |
H04L 29/06 20060101
H04L029/06; H04L 29/08 20060101 H04L029/08; H04W 12/06 20060101
H04W012/06 |
Claims
1. A system for obtaining electronic consent from a user, the
system comprising: a central computing system comprising logic for
executing computer readable instruction to cause the central
computing system to send and receive electronic data, the central
computing system comprising a processing unit, a memory component,
a data storage component, a visual display and a means for data
input; a mobile computing device comprising logic for executing
computer readable instruction to cause the mobile computing device
to send and receive electronic data to and from the central
computing system, the mobile device comprising a visual display and
a means for data input including a signature; and a purging module
of the central computing system and/or mobile computing device
comprising logic for purging some or all data from the mobile
device on signing the mobile device and transmitting some or all
data from the mobile device to the central computing system.
2. A system for obtaining electronic consent from a user
comprising: a central computing system capable of sending and
receiving electronic data, wherein the central computing system
comprises a processing unit, a memory component, a data storage
component, a visual display and a means for data input, further
wherein the computing system comprises logic for executing a
computer readable instruction module; a plurality of mobile
computing devices, capable of sending and receiving electronic
data, wherein each of the mobile devices includes a visual display,
an audio output means and a means for data input, further wherein
the mobile devices comprise logic for executing computer readable
instruction modules; a secure communication means for
electronically transmitting data between the central computing
system and each of the plurality of mobile devices, further wherein
the secure communication means has a limited range for transmitting
data; and a plurality of computer readable instruction modules
executable in the central computing system and the plurality of
mobile devices such that data can be shared between the central
computing system and the plurality of mobile devices, further
wherein at least one of the computer readable instruction modules
is a security module providing that user data is purged from the
mobile device.
3. A system for obtaining consent according to claim 2, wherein the
secure communication means for transmitting data between the
central computing system and each of the mobile devices is a Wi-Fi
connection.
4. A system for obtaining electronic consent according to claim 2,
wherein at least one of the computer readable instruction modules
provides customizable consent forms, wherein the customizable
consent form is customized for the individual user.
5. A system for obtaining consent according to claim 4, wherein the
secure communication means for transmitting data between the
central computing system and each of the plurality of mobile
devices allows the customizable consent forms to be transmitted to
a mobile device and a completed consent form to be returned to the
central computing system.
6. A system for obtaining electronic consent according to claim 2,
wherein the security module provides secure access to data on the
central computing system and on the plurality of mobile devices,
further wherein access is granted to a user's personal information
on a mobile device by entry of a password or PIN matching a preset
password or PIN.
7. A system for obtaining electronic consent according to claim 2,
wherein the data storage of the central computing system is an
internal storage component, an onsite storage component, or a cloud
based storage component.
8. A system for obtaining electronic consent according to claim 4,
wherein the computer readable instruction modules provide
customizable consent forms that are available in multiple
languages, such that the user may select a preferred language to
complete the consent forms on the mobile device.
9. A system for obtaining electronic consent according to claim 2,
wherein the data are forms that are viewable on the visual display
of the mobile device and editable through the input means of the
mobile device.
10. A system for obtaining electronic consent according to claim 2,
wherein the visual display is a touch screen such that the touch
screen is capable of visual display as well as use as a data input
means.
11. A system for obtaining electronic consent according to claim 2,
wherein data is purged from the mobile device at the end of each
user session or when the mobile device is beyond the communication
range of the secure communication means.
12. A system for obtaining electronic consent according to claim 2,
wherein a computer readable instruction modules comprise a timer
function, wherein the timer function is set to provide a limited
amount of time for a user session on the mobile device.
13. A system for obtaining electronic consent according to claim
12, wherein data is purged from the mobile device when the time for
the user session on the mobile device has expired.
14. A system for obtaining electronic consent according to claim 6,
wherein data is purged from the mobile device if after a set number
of attempts, the password does not match a preset password.
15. A computer based system for obtaining electronic consent
comprising: a central computing system capable of sending and
receiving electronic data, wherein the central computing system
comprises a processing unit, a memory component, a data storage
component, a visual display and a means for data input, further
wherein the computing system comprises logic for executing a
computer readable instruction module; a plurality of mobile
computing devices, capable of sending and receiving electronic
data, wherein each of the mobile devices includes a visual display,
an audio output means and a means for data input, further wherein
the mobile devices comprise logic for executing computer readable
instruction modules; a secure communication means for
electronically transmitting data between the central computing
system and each of the plurality of mobile devices, further wherein
the secure communication means is a WiFi connection having a
limited range for transmitting data; and a plurality of computer
readable instruction modules executable in the central computing
system and the plurality of mobile devices such that data can be
shared between the central computing system and the plurality of
mobile devices, further wherein at least one of the computer
readable instruction modules is a security module providing that
user data is purged from the mobile device.
16. A computer based system for obtaining electronic consent
according to claim 15, wherein the central computing system is a
computer readable storage medium storing logic for executing
computer readable instructions, when executed by a computer, cause
the computer to generate a customizable consent form, transmit the
consent form to a plurality of mobile devices, display the form on
the mobile device, receive and record user input using the mobile
device, transmit the consent form back to a central computing
system, store data using a data storage component.
17. A computer based system for obtaining electronic consent
according to claim 16, wherein at least one of the computer
readable instruction modules provides a customizable consent forms,
wherein the customizable consent form is customized for the
individual user and is visible to the user via the mobile
device.
18. A computer based system for obtaining electronic consent
according to claim 16, wherein the security module provides secure
access to data on the central computing system and on the plurality
of mobile devices, further wherein access is granted to a user's
personal information on a mobile device by entry of a password or
PIN matching a preset password or PIN.
19. A system for obtaining electronic consent according to claim
18, wherein data is purged from the mobile device if after a set
number of attempts, the password does not match a preset
password.
20. A computer based system for obtaining electronic consent
according to claim 16, wherein the data storage of the central
computing system is an internal storage component, an onsite
storage component, or a cloud based storage component.
21. A computer based system for obtaining electronic consent
according to claim 17, wherein the computer readable instruction
modules provide customizable consent forms that are available in
multiple languages, such that the user may select a preferred
language to complete the consent forms on the mobile device.
22. A computer based system for obtaining electronic consent
according to claim 16, wherein the data are forms that are viewable
on the visual display of the mobile device and editable through the
input means of the mobile device.
23. A computer based system for obtaining electronic consent
according to claim 16, wherein the visual display is a touch screen
such that the touch screen is capable of visual display as well as
use as a data input means.
24. A computer based system for obtaining electronic consent
according to claim 16, wherein data is purged from the mobile
device at the end of each user session or when the mobile device is
beyond the communication range of the secure communication
means.
25. A computer based system for obtaining electronic consent
according to claim 16, wherein computer readable instruction
modules comprise a timer function, wherein the timer function is
set to provide a limited amount of time for a user session on the
mobile device.
26. A computer based system for obtaining electronic consent
according to claim 25, wherein data is purged from the mobile
device when the time for the user session on the mobile device has
expired.
27. A network based system for obtaining electronic consent a
central computing system capable of sending and receiving
electronic data, wherein the central computing system comprises a
processing unit, a memory component, a data storage component, a
visual display and a means for data input, further wherein the
computing system comprises logic for executing a computer readable
instruction module; a plurality of mobile computing devices,
capable of sending and receiving electronic data, wherein each of
the mobile devices includes a visual display, audio output and a
means for data input, further wherein the mobile devices comprise
logic for executing computer readable instruction modules; a secure
communication means for electronically transmitting data between
the central computing system and each of the plurality of mobile
devices, further wherein the secure communication means has a
limited range for transmitting data; and a plurality of computer
readable instruction modules executable in the central computing
system and the plurality of mobile devices such that data can be
shared between the central computing system and the plurality of
mobile devices, further wherein at least one of the computer
readable instruction modules is a security module providing that
user data is purged from the mobile device.
28. A network based system for obtaining consent according to claim
27, wherein the secure communication means for transmitting data
between the central computing system and each of the mobile devices
is a Wi-Fi or Bluetooth connection.
29. A network based system for obtaining electronic consent
according to claim 27, wherein at least one of the computer
readable instruction modules provides a customizable consent form,
wherein the customizable consent form is customized for the
individual user.
30. A network based system for obtaining consent according to claim
29, wherein the secure communication means for transmitting data
between the central computing system and each of the plurality of
mobile devices allows the customizable consent forms to be
transmitted to a mobile device and a completed consent form to be
returned to the central computing system.
31. A network based system for obtaining electronic consent
according to claim 27, wherein the security module provides secure
access to data on the central computing system and on the plurality
of mobile devices, further wherein access is granted to a user's
personal information on a mobile device by entry of a password or
PIN matching a preset password or PIN.
32. A network based system for obtaining electronic consent
according to claim 27, wherein the data storage of the central
computing system is an internal storage component, an onsite
storage component, or a cloud based storage component.
33. A network based system for obtaining electronic consent
according to claim 29, wherein the computer readable instruction
modules provide customizable consent forms that are available in
multiple languages, such that the user may select a preferred
language to complete the consent forms on the mobile device.
34. A network based system for obtaining electronic consent
according to claim 27, wherein the data are forms that are viewable
on the visual display of the mobile device and editable through the
input means of the mobile device.
35. A network based system for obtaining electronic consent
according to claim 27, wherein the visual display is a touch screen
such that the touch screen is capable of visual display as well as
use as a data input means.
36. A network based system for obtaining electronic consent
according to claim 27, wherein data is purged from the mobile
device at the end of each user session or when the mobile device is
beyond the communication range of the secure communication
means.
37. A network based system for obtaining electronic consent
according to claim 27, wherein a computer readable instruction
module comprising a timer function, wherein the timer function is
set to provide a limited amount of time for a user session on the
mobile device.
38. A network based system for obtaining electronic consent
according to claim 37, wherein data is purged from the mobile
device when the time for the user session on the mobile device has
expired.
39. A network based system for obtaining electronic consent
according to claim 31, wherein data is purged from the mobile
device if after a set number of attempts, the password does not
match a preset password.
40. A method for obtaining user consent comprising steps of:
providing a central computing system and a plurality of mobile
devices, wherein the central computing system and the plurality of
mobile devices are coupled through a secure electronic
communication means, such that data can be transmitted and received
between the central computing system and each of the plurality of
mobile devices; providing a plurality of computer readable
instruction modules on the central computing system and the
plurality of mobile devices such that data can be shared between
the central computing means and the plurality of mobile devices;
creating customized data forms that are customized to an individual
user, wherein the customized data forms are created using a
computer readable instruction module on the central computing
system; transmitting the customized data forms from the central
computing system through the secure electronic communication means
to the plurality of mobile devices; granting the user secure access
to the customized data forms from a mobile device, wherein secure
access is provided through a computer readable instruction modules
providing security to the data; providing a display screen and a
data input means on the mobile device to allow the user to review
the customized data forms, edit data and attest consent; providing
a plurality of audible or visual alerts to the user through a
computer readable instruction module; transmitting the completed
customized data forms from the plurality of mobile devices back to
the central computing system; reviewing the completed customized
data forms; storing the completed customized data forms in a secure
electronic file; purging the mobile device of personal data.
41. A method for obtaining consent according to claim 40, wherein
the secure communication means for transmitting data is a Wi-Fi
connection, having a limited transmission range.
42. A method for obtaining consent according to claim 40, wherein
granting the user secure access to the customized data forms on the
plurality of mobile devices requires that the user enter a password
or PIN that matches a preset password or PIN.
43. A method for obtaining consent according to claim 40, wherein
the customized data forms are available in a multiple languages and
further wherein the language the customized data form is displayed
is a language selected from the multiple languages available.
44. A method of obtaining consent according to claim 40, wherein
the customized data forms contain multiple pages and further
wherein the user can navigate though the multiple pages of the
customized consent form to review, edit, bookmark, or attest
consent.
45. A method of obtaining consent according to claim 40, wherein
data is purged from the mobile device after the completed data
forms are transmitted back to the central computing device.
46. A method of obtaining consent according to claim 41 wherein
data is purged from the mobile device when mobile device is moved
beyond the transmission range of the communication means.
47. A method of obtaining consent according to claim 40 wherein
reviewing the completed forms is done by an authorized personnel or
by a computer readable instruction modules.
48. A method of obtaining consent according to claim 40 wherein the
completed forms are stored in a storage means onsite or stored in a
cloud storage means.
49. A method obtaining electronic consent according to claim 40,
wherein a computer readable instruction modules comprise a timer
function, wherein the timer function is set to provide a limited
amount of time for a user session on the mobile device.
50. A method of obtaining electronic consent according to claim 49,
wherein data is purged from the mobile device when the time for the
user session on the mobile device has expired.
51. A method of obtaining consent according to claim 40, wherein
the plurality of alerts may indicate incomplete data in the
forms.
52. A method of obtaining consent according to claim 49, wherein
the plurality of alerts may indicate a limited amount of time for a
user session on the mobile device.
53. A method for obtaining patient consent comprising steps of:
providing a central computing system and a plurality of mobile
devices, wherein the central computing system and the plurality of
mobile devices are coupled through a secure electronic
communication means, such that data can be transmitted and received
between the central computing system and each of the plurality of
mobile devices, further wherein the secure electronic communication
means has a limited transmission range; creating customized data
forms that are customized to an individual user, wherein the
customized data forms are created using a computer readable
instruction modules on the central computing system, further
wherein the customized data forms may provide that some forms are
pre-populated with data specific to a user; transmitting the
customized data forms from the central computing system through the
secure electronic communication means to the plurality of mobile
devices; granting the user secure access to the customized data
forms from a mobile device, wherein secure access is provided
through a computer readable instruction modules providing security
to the data; providing a display screen and a data input means on
the mobile device to allow the user to review the customized data
forms, edit data or attest consent, further wherein the display
screen is a touch screen such that the user can input data using
the display screen; providing a computer readable instruction
modules that provide a time limit on reviewing the customized
forms, editing the data or attesting consent, further wherein
periodic audible or visual alerts are provided to the user to
advise the user of the remaining time, further wherein the user may
be prompted for action if time expires prior to the user completing
the customized data forms; transmitting the completed customized
data forms from the plurality of mobile devices through the secure
electronic communication means back to the central computing
system; reviewing the completed customized data forms, wherein the
review of the completed customized data forms is performed by an
authorized personnel; storing the completed forms in a secure
electronic file, wherein the secure storage means may be onsite or
cloud based storage; purging the mobile device of personal data,
wherein the mobile device is purged after completed data forms are
transmitted back to the central computing system, if the plurality
of mobile devices is removed beyond the transmission range of the
communication means, or if the time expires prior to the user
completing the customized data forms and the user does not take
appropriate action to extend the amount of time to complete the
customized data forms.
Description
BACKGROUND
[0001] There are many processes that require a user to authorize or
grant consent for an action. The process for approval requires that
an individual is made aware of key information and acknowledges
that he or she understands the information that has been presented.
The acknowledgement of understanding, usually in the form of a
signature or the affixation of an identifying mark that is unique
to the individual, is then documented and maintained for the
record.
[0002] Authorization and consent forms, similarly to contract
agreements, provide important information regarding an act or
service and allow an individual to acknowledge and agree to the
terms provided. When an individual affixes his or her signature to
a consent form, he or she acknowledges that they have read the
information and authorize the act or service described in the form,
subject to any identified conditions. Thus obtaining authorization
for an action and maintaining sufficient record of the consent is
important to document the understanding of the parties and to
protect against false claims and assertions misunderstandings.
[0003] In the past, many consent documents were processed manually
with paper forms that required handwritten signatures attesting
consent. This process created many challenges. Specifically,
maintaining consent forms for a variety of processes could yield
volumes of paper to be organized and filed. Additionally, in a
multilingual society, it is also important to ensure that the
individual is able to receive instructions or information in a form
that ensures that the user understands the documents to be
completed and signed. Thus, maintaining paper consent documents in
multiple languages can create an even greater burden.
[0004] Even in cases where forms are printed on an as-needed basis,
there is still an issue with storage and filing. Particularly, in
many cases manual forms are stored in traditional storage cabinets.
Those cabinets not only take up a significant amount of space, but
human error could also lead to misfiled or lost paperwork.
Furthermore, even when digital storage is available, the paper
documents must be stored temporarily or scanned immediately and
then destroyed. Regardless of whether paper forms are stored
temporarily or long-term, many consent forms may contain personal
or private information that should be protected and secured at all
times. Manual processing leaves personal information open to the
possibility of being mishandled. Paper forms may be mislaid or even
removed from a file and thus leave an individual's personal
information vulnerable to criminal activity such as identity theft
or other misuse.
[0005] Protecting personal information is especially critical when
it comes to medical records. In hospitals and clinical settings,
capturing patient information and securing consent from a patient
is a routine part of the patient registration and treatment
process. With few exceptions, the patient must provide consent
prior to any medical services being rendered. In completing intake
and consent forms, the process can require that a person read and
review lengthy documents and attest understanding. This process can
be complicated if the documents are not offered in the patient's
native language. A lack of understanding often results in forms
that are incomplete or improperly signed, wasted paper, and an
overall loss of time and efficiency in the medical treatment
process. Furthermore, medical consent forms often contain personal
information that should be protected in accordance with the
law.
[0006] Currently, there is no system that allows for customized
consent forms to be generated and offered to an individual
electronically, wherein the individual can complete the forms and
attest consent as required, and electronically submit the forms for
electronic filing, ensuring that the individual's personal
information remains protected throughout the authorization process.
Furthermore, there is no system that provides notification for
documents requiring a witness or additional signatures.
Additionally, there is no system that provides that personal or
otherwise user sensitive data is deleted from any remote device
once the consent is received for storage on a secure computing
system.
[0007] New systems and methods for securing consent are needed.
Specifically, systems and methods that can be used to obtain the
consent of an individual through electronic processing such that
the personal information of an individual is secured and protected.
The consent process can be customized to include only the
documentation that is necessary for the individual to authorize and
can be offered in the language that the individual selects. Further
all personal or sensitive data is purged from a remote device once
consent has been provided. The new systems and methods allow for
faster processing with fewer mistakes and greater accuracy as well
as better protection for personal user data.
SUMMARY
[0008] New systems and methods for obtaining electronic
authorization are provided. One advantage of the present system is
to provide a centralized computing system capable of electronically
linking to a plurality of electronic mobile devices. The
centralized computing system is able to transmit and receive data
between the computer and each of the electronic mobile computing
devices. In one embodiment, the data is transmitted via a secure
wireless network that ensures that personal information remains
protected. In one embodiment the secure data transmission involves
data encryption methods.
[0009] Another advantage of the electronic consent system is the
ability to incorporate computer readable instructions, such a
software program, such that data can be shared between the central
computing system and each of the mobile devices. In one embodiment,
software code or logic will allow documents to be readable and
editable from the central computing system as well as on a mobile
device. In some cases, the computer readable instructions may be
pre-loaded on each system when the computer systems are assembled
(e.g., special order systems built to specification including
software and applications) or it may be manually loaded using for
example, installation disk, CDs, or other connectable data drives
(e.g., flash drives). Alternatively, the software is downloadable
via an online Internet source. Software upgrades and updates for
maintaining or enhancing the capabilities and functions of the
systems and methods may also be available for download through an
Internet website.
[0010] Another advantage of the electronic consent system is the
ability to customize the data that is shared between the central
computing system and each of the mobile devices. Unique data and
consent forms can be pushed or transmitted from the centralized
computing system to each of the mobile devices. The specific forms
that are transmitted to each of the mobile devices depend on the
authorization that is requested by the individual using the mobile
device. In various embodiments, the documents transmitted from the
central computing device to one of the plurality of mobile devices
would be similar to those transmitted to another mobile device. In
other embodiments, the documents transmitted to a mobile device
would be different in each of the mobile devices. In each case, the
documentation transmitted from the central computing system to each
of the mobile devices would be specific to the authorization forms
that the individual user is required to complete. In various
embodiments, the forms will contain personal information specific
to each user. In some embodiments, the forms contain pre-filled
information specific to the individual user and in some
embodiments, the user can input personal information through the
mobile computing device.
[0011] Another advantage of the system provides that the mobile
device is enabled with security features such that no personal
information is retained on the mobile device. Each time personal
information is transmitted from the mobile device back to the
central computing system, the mobile device is purged of all
personal information pertaining to the individual user. In one
embodiment, the software and security settings will comply with at
least the minimum standards for maintaining personal data such as
medical records. In yet another exemplary embodiment, the mobile
device is further equipped with safety settings such that any
perceived breach in security results in the mobile device being
wiped clean of data, such as personal information pertaining to the
individual user.
[0012] In one embodiment the method of obtaining electronic consent
comprises generating unique documents or authorization forms for
each individual user. In various embodiments the forms are
electronically transmitted to a mobile device. The individual whose
consent is sought is able to securely access the consent forms via
the mobile device. The individual is able to review the documents
and affix his or her electronic signature to each of the required
forms. Upon providing consent, the forms are securely transmitted
back to the central computer for review and storage. In one
embodiment completed forms are stored remotely via a secure server
system or other secure electronic data storage means. Additional
embodiments provide that the completed forms are accessible by
authorized personnel.
[0013] In the following detailed description of the present
disclosure, reference is made to the accompanying drawings that
form a part hereof, and in which is shown by way of illustration
how examples of the disclosure may be practiced. Additional
features and advantages of various embodiments will be set forth in
part in the description that follows, and in part will be apparent
from the description, or may be learned by practice of various
embodiments. These examples are described in sufficient detail to
enable those of ordinary skill in the art to practice the examples
of this disclosure, and it is to be understood that other examples
may be utilized and that process and/or structural changes may be
made without departing from the scope of the present disclosure.
The objectives and other advantages of various embodiments will be
realized and attained by means of the elements and combinations
particularly pointed out in the description and appended
claims.
BRIEF DESCRIPTION OF THE DRAWINGS
[0014] In part, other aspects, features, benefits and advantages of
the embodiments will be apparent with regard to the following
description, appended claims and accompanying drawings where:
[0015] FIG. 1 illustrates a basic overview of the electronic
consent system. In the illustrated embodiment, a plurality of
mobile devices are shown to connect with the central computing
system. This illustrated embodiment is not intended to limit the
number or type of devices that are operable with this system.
[0016] FIG. 1A illustrates a basic overview of the electronic
consent system of FIG. 1. In the illustrated embodiment, the
central computing system is in communication with a patient's
electronic medical records, which can be accessed from electronic
medical records work stations.
[0017] FIG. 2 illustrates a basic computer architecture including
basic components of exemplary computing devices.
[0018] FIG. 3 illustrates an embodiment of the system architecture
that incorporates computer readable instructions that allow
customized user forms to be generated through a central computing
device and mapped to mobile devices.
[0019] FIG. 3A illustrates an embodiment of the system architecture
of FIG. 3. In the illustrated embodiment, the form engine is in
communication with data storage and is configured to access a
patient's electronic medical records through web services.
[0020] FIG. 4 illustrates an exemplary form type that the user may
be given to provide electronic consent through mobile device.
[0021] FIG. 5 illustrates an embodiment of the method of obtaining
consent where documents are transmitted from a central computing
system to an end user on a mobile device, and upon review and
authorization, the documents are returned to the central computing
system.
[0022] FIG. 5A illustrates an embodiment of the method of obtaining
consent of FIG. 5. In this illustrated embodiment, the method
further comprises validating the user.
[0023] FIG. 6 illustrates an embodiment of a security module that
can be implemented to maintain the security of personal data.
[0024] FIG. 6A illustrates an embodiment of a security module of
FIG. 6.
[0025] FIG. 7 illustrates an embodiment of a login screen where a
user is able to enter his or her registered personal credentials in
order to securely access his or her personal document queue.
[0026] FIG. 8 illustrates an exemplary embodiment of a process flow
in a health care environment.
[0027] FIG. 8A illustrates an exemplary embodiment of a process
flow in a health care environment of FIG. 8.
[0028] It is to be understood that the figures are not drawn to
scale. Further, the relation between objects in a figure may not be
to scale, and may in fact have a reverse relationship as to size.
The figures are intended to bring understanding and clarity to the
structure of each object shown, and thus, some features may be
exaggerated in order to illustrate a specific feature of a
structure.
DETAILED DESCRIPTION
[0029] For the purposes of this specification and appended claims,
unless otherwise indicated, all numbers expressing quantities and
other numerical values used in the specification and claims are to
be understood as being modified in all instances by the term
"about." Accordingly, unless indicated to the contrary, the
numerical parameters set forth in the following specification and
attached claims are approximations that may vary depending upon the
desired properties sought to be obtained by the present
invention.
[0030] It is noted that, as used in this specification and the
appended claims, the singular forms "a," "an," and "the," include
plural referents unless expressly and unequivocally limited to one
referent. Thus, for example, reference to "a mobile device"
includes one, two, three or more mobile devices.
[0031] Reference will now be made in detail to certain embodiments
of the systems and methods provided in this application, examples
of which are illustrated in the accompanying drawings. While the
systems and methods will be described in conjunction with the
illustrated embodiments, it will be understood that they are not
intended to be limited to those embodiments. On the contrary, the
systems and methods are intended to cover all alternatives,
modifications, and equivalents as defined by the description and
appended claims.
[0032] New systems and methods, which can more easily and
efficiently allow a user to access a customized set of form
documents and attest consent and authorization are provided. In
some embodiments, there is a system for obtaining electronic
consent from a user, the system comprising: a central computing
system comprising logic for executing computer readable instruction
to cause the central computing system to send and receive
electronic data, the central computing system comprising a
processing unit, a memory component, a data storage component, a
visual display and a means for data input; a mobile computing
device comprising logic for executing computer readable instruction
to cause the mobile computing device to send and receive electronic
data to and from the central computing system, the mobile device
comprising a visual display and a means for data input including a
user's signature; and a purging module of the central computing
system and/or mobile computing device comprising logic for purging
some or all data from the mobile device on the user signing the
mobile device and transmitting some or all data from the mobile
device to the central computing system. In this way, after the
mobile device is electronically signed, (e.g., by digital
signature, certificate, etc.), some or all data is purged from the
mobile device by the user transmitting the signature to the central
computing system. In some embodiments, all data from the mobile
device is purged from the device except the unique identifier that
allows the central computing system to send new data to the mobile
device.
[0033] In some embodiments, there is a mobile computing device for
obtaining electronic consent, the mobile computing device
comprising logic for executing computer readable instruction to
cause the mobile computing device to send and receive electronic
data to and from a central computing system, the mobile device
comprising a visual display and a means for data input including a
user's signature; and a purging module of the mobile computing
device comprising logic for purging some or all data from the
mobile device on the user signing the mobile device and
transmitting some or all data from the mobile device to the central
computing system.
[0034] In some embodiments, there is a central computing system for
obtaining electronic consent, the central computing system
comprising logic for executing computer readable instruction to
cause the central computing system to send and receive electronic
data to and from a mobile computing device, the central computing
system comprising a visual display and a means for data input; and
a purging module comprising logic for purging some or all data from
the mobile device on the user signing the mobile device and
transmitting some or all data from the mobile device to the central
computing system.
[0035] The electronic consent system in FIG. 1 comprises a central
computing system (101) electronically coupled to various devices.
In various embodiments the computing system comprises a
user-operated terminal, including a visual display, a means for
data input as well as a means for processing data transactions. The
central computing system may comprise an internal data storage
component for storing electronic data files and records. In one
embodiment, the system may also comprise external storage
components such that data can be stored independently of the
central computing system (104). External storage may be onsite via
any data storage means, such as an onsite server or data may also
be stored offsite through a remote cloud storage means.
[0036] In one embodiment the central computing system is
electronically connected (103) to a data storage means as well as
to a plurality of mobile computing devices (102). Each of the
mobile devices will be equipped with a screen for providing visual
display of data and an input means to input data into the mobile
device. In various embodiments, exemplary mobile devices may
include portable computing systems such as a laptop computer, a
tablet computer, or any type of portable device configurable to
provide a visual display to the user, accept user input, and
process data. In some embodiments, the mobile device will allow
data entry via means such as a keypad (real or virtual), touch
screen selection (e.g., touching screen to highlight choice),
manual screen input (e.g., writing on the screen with appropriate
instrument such as a stylus), or voice capture (e.g., either
convertible to text or stored as audio file). In some embodiments,
the mobile device will include audio output means such as built-in
speakers or a standard audio socket that receives a jack to allow
speakers such as headphones or earphones to connect to the mobile
device and to project sound.
[0037] In one embodiment, the central computing system and each of
the plurality of mobile computing devices are equipped with
compatible computer readable logic or instructions such as a
software program to execute a variety of data processing modules
and commands. In some embodiments the computer readable
instructions allow data to be shared between the central computing
system and each of the mobile devices. Employing compatible
software programs across devices will allow forms and documents to
be consistently viewed and edited in the central computing system
as well as in any of the plurality of mobile devices.
[0038] In various embodiments, the central computing system and the
mobile devices will contain computer readable instructions such
that the systems are capable of web-based communications. In
various embodiments, data entered using the central computing
system may be accessed via a secure web interface available using
the mobile device and data entered using the mobile device may be
accessed via a secure web interface available on the central
computing system.
[0039] In one embodiment, as shown in FIG. 1A, the central
computing system (101) is in communication with a patient's
electronic medical records (EMR) (105) which can be accessed from a
plurality EMR work stations (106). In this way, a timing module in
the central computing system 101 can transmit and receive data to
and from the electronic medical record computer (EMR) 105 in a
certain period of time and this data can be sent and received to
and from the plurality of electronic work stations 106. In this
way, if there is a delay in completing the consent form of a slow
first user and the second user is already done with the consent
form, the central computing system 101 can bypass the slow first
user and send data to and from the EMR 105 to the work station 106,
so that there is no bottle neck caused by the slow first user.
[0040] For example, if mobile device user 1 in 102 is slow at
completing the data in the paperless consent form, the mobile
device user 2, who is a fast user and has completed the data, can
transmit the data to the central computing system, where the timing
module will keep track of time for submission. Central computing
system 101 can send and receive data from mobile device of user 2,
because this user has completed the consent form first, to EMR 105
and then to EMR work stations so that there is no delay caused by
mobile device user 1. This can be done by a timing module in
central computing system 101, EMR 105, and/or in the EMR work
station 106. An alerts generator can transmit and alert to the
mobile device 102 for device 1, after a certain time, indicating
that the electronic form has not been completed.
[0041] In some embodiments, the mobile device (e.g., IPAD, tablet,
MS Surface, Android, etc.) can automatically purge any existing
data should the electronic form not be completed within a certain
period of time. Thus the timing module and purging module can work
together to purge the data. The timing module and/or purging module
can be in the central computing system 101, in the EMR 105, in the
EMR work station 106, and/or in the mobile device 102.
[0042] In some embodiments, the mobile device 102 does not have the
capability to store and medical record data so that if the device
is lost or stolen, there will be no data storage capability. In
this embodiment, the data storage is a remote data storage 104 and
not on the actual device itself. In some embodiments, only HTML
data is stored on the device and not PDF data.
[0043] In some embodiments, the EMR work station 106 comprises a
monitoring module to monitor the mobile devices 102 to insure the
electronic forms are completed within a certain period of time or
allow one fast user to bypass a slower user.
[0044] FIG. 2 illustrates an exemplary model of a central computing
system. Basic components of computing systems are understood and
this figure shows typical components required for providing
computing functionality. Other models and iterations of a computer
system would also be understood and deemed acceptable within the
spirit of this application. The central computing system comprises
a central processing unit ("CPU") (201) for processing instructions
and mapping interactions between components. The CPU is coupled
with memory (202) enabling the processor to execute instructions
and commands. In exemplary embodiments, memory such as random
access memory (RAM), magnetic memory such as a hard disk, floppy
disk, and/or tape memory, a solid state drive (SSD), flash memory,
phase change memory, etc are acceptable. The central computing
system also comprises data storage devices (204). In some
embodiments storage is internal to the system via a hard disk or
removable via CD/DVD or other portable memory drives (e.g., flash
storage). The system may also be electronically connected to
external storage such as a server system or remote cloud storage.
In various embodiments the central computing system also comprises
an input means (203) such as a keyboard (real or virtual) a mouse,
a stylus, or any other tool for communicating information to the
system. The central computing system also comprises an output
device such as a visual display (205) in order to project
information from the system to a user.
[0045] In one embodiment, forms or documents requiring attestation
of consent will be generated via for example, a form generating
software module provided on the central computing system. A unique
combination of forms and documents can be customized for each
individual user. The combination of forms represents only the forms
that require a particular user's consent. Customizing the
authorization forms help to simplify and expedite the consent
process. In the embodiment shown in FIG. 3, exemplary software such
as iClinic 12.1.RTM. (301) may be provided on a computing system
(101). The exemplary software allows the personal information to be
mapped (302) to individual medical records stored in a database,
which could either be a component of the central computing system
(as shown) or a remote storage unit. The form creation module (303)
of the software then creates the appropriately formatted forms to
be sent to each individual user based on the user's mobile
device.
[0046] In some embodiments, parts of the document are static, i.e.,
they are only readable while other parts of the document allow the
user to edit certain fields. Specifically, fields may be edited to
include the user's personal information or personal answers to
questions presented in the document. The forms and documents may be
such that they can be read and edited via the central computing
system or the mobile device. The embodiment shown provides that the
documents are created in a portable document format, such as
Adobe.RTM. PDF, and then transmitted via an electronic
communication means (304) to a mobile device. After the user has
completed the forms, the user can submit the PDF, including user's
electronic consent, back to a central computing system for review
and/or storage (305).
[0047] In one embodiment, the method of obtaining consent comprises
providing custom forms to the user. Specifically, a unique set of
forms can be generated that are specific to the consent sought from
a particular user. The forms and documents that are generated may
require the user to input all personal data whereas other
embodiments may allow some personal data to be pre-populated into
the form from a variety of sources. In some exemplary embodiments,
some personal user data may be pre-filled into the form based on
personal information stored in a secure database such as a user's
electronic file (e.g., Patient Electronic Medical Record) or other
previously completed data forms. In several embodiments, the forms
may comprise a combination of pre-populated information and fill-in
blanks for the patient to enter specified information.
[0048] In the exemplary embodiment illustrated and described in
FIG. 3, the PDF type format provides that the document appearance
is consistent between viewing devices. Other file formats that
allow the file to be viewed and edited are also considered. In the
present embodiment, only certain fields of the document may be
modified, while other text including instructions and questions to
be answered are static and cannot be edited.
[0049] In one embodiment, as shown in FIG. 3A, the form engine is
in communication with data storage (101) and is configured to
access a patient's electronic medical records (EMR) (301) through
web services. In some embodiments, only HTML data is stored on the
device and not PDF data. The HTML data can be used to generate a
time and date stamp on the PDF form that is transmitted to and from
and stored on form engine module 303, where it can be stored on a
separate data storage module 101. The medical record data can be
transmitted to and from the EMR module or computer 301. In this
way, the engine form generator 303 can generate the sufficient
number of forms and transmit and receive data including the HTML
data from the mobile devices (tablet, surface, labtop, IPAD, etc.)
so that there is no bottle neck in the system due to the number of
users, or slow users, or insufficient number of electronic forms
generated. Communication between the form engine 303 and the
electronic medical record (EMR) 301 can be accomplished via the
web.
[0050] In an exemplary form shown in FIG. 4, the form is viewable
via a web-based interface (401). The document provides blocks of
static text in the form of questions that the user cannot modify
(402). In the present embodiment, user identification information
such as name and file number may be manually input into the forms
(403), while in other embodiments, that exemplary information may
be pre-filled from a database and may or may not be editable by the
user. Exemplary embodiments may provide the form includes blank
lines (404) or text boxes to denote the parameters for user input.
In various embodiments standard word processing editing tools
(e.g., spell check, cut, copy, paste, etc.) may be provided for
editing user text input. In other embodiments of forms, other means
of user input are also possible. In some embodiments, the forms
provide check boxes that allow a user to select between options by
clicking a radial button, a check box, or another means of
highlighting or indicating a user selection (405). In some
embodiments, a user may be required to "check a box" to indicate
that the user has read or otherwise reviewed certain information.
Additionally, in various embodiments, forms will provide a place
for the user to provide consent via signature or input of another
form of acceptable attestation of consent (e.g., PIN) (406). In
some embodiments, each form may also include a several options that
allow a user to for example, return to a previous screen, move to
the next form in the queue or complete and submit the documents if
the user has reached the end of the document queue (407).
[0051] In various embodiments, a plurality of forms or documents
may be sent to a mobile device to obtain a user's consent or
authorization. In some embodiments the forms may be documents
related to a single purpose (e.g., consent for a specific medical
procedure such as colonoscopy). In other embodiments the forms
could be related to multiple purposes that require the user's
consent (e.g., consent for a colonoscopy, blood work, and an
EKG).
[0052] Various embodiments of the forms provide that personal
information such as name, address and phone number are collected
from the user or verified by the user. In other embodiments, other
information that may be used to uniquely identify the user may be
provided or requested. For example, the user's social security
number, a case number or file number assigned to the user,
insurance information, credit card information, or any other
information that is linked to a user's identity may be required.
Still other exemplary embodiments of forms may provide other
sensitive information pertaining to specific user. For example, the
form may provide information such as employment history, criminal
background, or in a medical context, the form may provide
information specific to the user's medical treatment or regarding
the user's medical history.
[0053] In various embodiments the forms provided may include any
documents that require a user to read instructions or directives or
other information and provide acknowledgment. Some embodiments
provide that forms allow the user to input information into a
document and acknowledge information provided in a document.
Exemplary forms types may include but are not limited to medical
patient intake, medical treatment consent, surgery authorization,
acknowledgment of risk of procedure or process, post-procedure
instructions, a "do not resuscitate" order, insurance approval
documents, billing statements, payment authorizations, contractual
agreements, etc.
[0054] FIG. 5 illustrates various embodiments of a method of
obtaining informed user consent. The selected combination of forms
and documents are transmitted (501) to one of the plurality of
mobile devices connected to the central computing system. In some
embodiments, the electronic communication means (103) is a
network-based system such as a secure wireless local area network
(WLAN). In exemplary embodiments the communication network is a
Wi-Fi connection, Bluetooth type connection, or any other available
connection that will support the secure transmission of data
between devices. In various embodiments the range of the wireless
transmission signal will provide physical limitations to the
location of the connected mobile devices.
[0055] A wireless communication system operating in accordance with
the widely used 802.11 WLAN protocol is used herein as a primary
example of a WLAN. An understanding of the 802.11 protocol (Direct
Sequence Spread Spectrum, or DSSS), which is publicly available
from IEEE (Institute of Electrical and Electronics Engineers), is
assumed. Thus, a detailed description of the operation and
components of a WLAN is not provided herein. However, various
aspects of the invention are not limited to use with a WLAN, much
less an 802.11 compliant WLAN.
[0056] In various embodiments, the computer readable instructions
provided on the mobile device will allow the user to select the
language that the user would like to the complete the consent forms
in. This ensures that the user is able to understand the documents
that he or she is attesting consent to. In various embodiments, the
language selection is made from central computing system or from
the mobile device. In some embodiments, the user may indicate
language selection such that computer readable instructions provide
that forms are generated in user's pre-selected language prior to
transmission to the mobile device. In other embodiments, computer
readable instructions provide that forms are generated and
transmitted to the mobile device where the user may then select the
desired language by for example, clicking an icon, choosing from a
drop-down, or any other means of indicating a selection.
[0057] Various embodiments provide that the forms or documents are
visually presented to the individual user on one of the plurality
of mobile devices. In one embodiment of the system, the user can
read and review (502a) the forms via the visual display on the
mobile device. In one embodiment of the system, as shown in FIG.
5A, the user is validated prior to the user reading and reviewing
the forms. Some embodiments employ computer readable instructions
that provide, for example visual prompts, pop-up text, or dialogue
boxes that provide additional explanation or clarification
regarding the forms and the information presented to the user. The
user can also edit data and input data (502b) into the form via an
input means such as a keyboard, keypad, or touch screen. In some
embodiments, the computer readable instructions on the mobile
device can be configured to support voice input from the user.
[0058] In various exemplary embodiments, the computer readable
instructions also provide that the forms may be provided to a user
audibly. Specifically, a user is provided audible instructions that
guide the user through inputting information and providing consent.
Audio instructions may also provide clarification or further
explanation regarding completing forms that may assist the user in
providing informed consent. In various embodiments, audio
instructions are provided in a plurality of languages such that a
user may select the language that he or she would prefer to receive
instructions. In various embodiments, the user may request that the
audio instructions are repeated in whole or in part. In some
embodiments, the user may also control the speed in which the audio
instructions are provided allowing the audio delivery to be slowed
to increase user comprehension.
[0059] In various embodiments, the user may be presented with
multiple documents to review and consent to or the user may be
presented with a single document comprising multiple pages of
information. In an exemplary embodiment, the user may click, tap,
swipe, scroll or otherwise navigate through the documents to go
forward or backward within a single document with multiple pages or
between a plurality of documents. In some embodiments the user may
be required to affix an electronic signature at certain specified
points on the form before the document will advance.
[0060] In other embodiments, the computer readable instructions
mobile device may allow the user to flag or otherwise mark any
areas of the form that the user would like assistance with or
additional information to complete. In some embodiments, flagging
the form may immediately send a notification to the central
computing system, alerting someone, such as office staff or other
personnel, to offer assistance to the user. In other embodiments,
flagging may serve as a bookmark to mark an area that the user
needs to return to complete. In exemplary embodiments, the user may
be provided an alert to notify him or her of incomplete information
or sections that need to be complete prior to submission. Some
embodiments may prevent the user from moving on to new pages,
sections or documents until incomplete sections have been
completed.
[0061] Various embodiments provide computer readable instructions
that allow for regular backup of the mobile device. In an exemplary
embodiment, the contents of the mobile device are saved at
consistent time intervals to temporary storage. Providing regular
backup allows for the most recent file to be recalled in the event
of sudden loss of power to the mobile device. In some embodiments,
the data file is temporarily stored on the mobile device and can be
recovered. In some embodiments the data file is temporarily stored
via a cloud computing system. In some embodiments, the data file is
synchronized with the central computing system and is temporarily
stored on the central computing system.
[0062] In various embodiments, upon review and attestation of
consent (502c) on all required forms or documents, the completed
(502d) forms are submitted (502e) from the mobile device. Upon
submission, the documents are transmitted back (503) to the central
computing system (101) via the secure wireless communication
network (103).
[0063] In an exemplary embodiment, when the data is submitted from
the mobile device, it is encrypted for transmission and then
readable at the central computing system. When the data files are
synchronized such that all data input entered via the mobile device
has been transmitted to the central computing system, the central
computing system is complete with a duplicate of the information
that submitted by the user via the mobile device. When all data
files have been synchronized, the data may be stored via a storage
means and purged from the mobile device.
[0064] In some embodiments, authorized personnel can review
completed documents using the central computing system. In other
embodiments, the software allows the documents to be scanned for
completeness and accuracy. In one embodiment, the completed consent
document is stored onsite. In other embodiments, the completed
documents are transferred via secure transmission for secure,
off-site storage.
[0065] In various embodiments, computer readable instructions
provide that the documents are marked with a time and date stamp
upon completion. Some embodiments provide that the documents are
time and date stamped when the user affixes a signature, submits
the documents to the central computer, or when the central
computing system receives the documents. The timestamp that is
affixed to the document may appear on the face of the document or
may also be electronically encoded in the document metadata. In
various embodiments, the timestamp is associated with the
electronic signature as a means of validating date and time of
consent. In additional embodiments, the timestamp allows the
document to be filed and traced for reference.
[0066] In some embodiments, consent forms require input from
multiple individuals. When input from multiple individuals is
required, some embodiments may require that each individual
providing input, such as a signature attesting consent, will be
provided with a single mobile device such that each user will use
the same device to complete form and provide consent. In some
embodiments, a first user may complete all forms, providing consent
and then the forms may be reset to allow a second user to provide
consent where required. In various embodiments, upon completion,
the first user will be prompted to transfer the mobile device to
the second user and upon completion, the second user may be
prompted to submit documents to end the session. In a case where
more than two users are required to input data, the process may be
repeated until all required signatures have been obtained. In other
embodiments, where a form requires input form multiple users, for
example, a first user may only move to complete a second form only
after a first form has been completed by all users.
[0067] In another exemplary embodiment where input is required from
multiple users, each user has his or her own mobile device to
provide input. In an embodiment where multiple devices for multiple
users is employed, the documents may be shared using a cloud
computing document sharing services, (e.g., similar to Google
Docs). In various embodiments, multiple users may view and provide
consent on forms simultaneously.
[0068] FIG. 6 illustrates an additional embodiment of the consent
system using computer readable instructions that provide a security
module to ensure that personal information is protected. One
embodiment requires the use of personal credentials such as a
personal login, PIN, or password to access documents. In some
embodiments, personal credentials may be set through a software
module, designed to provide secure access to data. The software
module may be available through the central computing system, the
mobile devices or through a secure web-interface. In various
embodiments, the unique user credentials may be set from the
central computing system (601) and then required to access forms on
the mobile device (603a). In one embodiment, as shown in FIG. 6A,
if the password is not entered, the user is prompted to answer a
challenge question, such as for example, their zip code, phone
number or random data from the form. Passwords entered on the
mobile device are compared to the preset password (603b). Only if
the passwords match will the user have access to review and provide
consent (603c) on the forms. In some embodiments, the system may be
"locked," denying user access, after a set number of failed
attempts to enter the correct password. In some embodiments, the
mobile device can be registered as shown in 102 of FIG. 6A, where
the device has a unique identifier that the central computer can
recognize and transmit and receive data to and from it. The unique
identifier can be a unique number, code or encryption, digital
certificate or the like that causes the central computer to
recognize it as an approved device to transmit and receive data to
and from it.
[0069] In other embodiments, user credentials may be set through a
secure web portal and required to access documents on the mobile
device. Passwords and credentials may be a combination of
alphanumeric characters that are selected by the use or become
known to the user such that the user has exclusive access to his or
her personal account. Still other embodiments may employ other
credentials to access secure information such as a unique value
assigned to the user, a biometric input (e.g., finger print scan),
or any other identifier that allows the user secure access to forms
via the mobile device. The requirement of user credentials to
access forms ensures that the user is granted access to only the
unique combination of forms requiring his or her consent as well as
ensures that any personal information remains private and
secure.
[0070] Other exemplary embodiments may provide that the mobile
device itself is assigned a unique identifier that can be
associated with a specific user. The software used in conjunction
with the system may map the unique user forms to a specific mobile
device such that once the documents have been mapped, only the
specified user can access the device with a unique password or
code.
[0071] In various embodiments, the software instructions on the
mobile devices are equipped with additional security measures. In
one embodiment, after completion (603d) the user may "submit"
(603e) the authorized documents from the mobile device through a
secure transmission (602) to the central computing system. After
the submission is confirmed, all personal data may be immediately
cleared or otherwise permanently deleted (6030 from the memory of
the mobile device. In some embodiments, the user may receive
notification that the mobile device will be purged of all data
after confirming submission of signed documents and in other
embodiments, the purging may occur without notice.
[0072] In some embodiments, when purging occurs the user's personal
or sensitive data, such as name, address, telephone number, social
security, case or file number, credit card number, criminal
history, medical history, etc. is deleted from the mobile device.
In other embodiments, in addition to personal information
pertaining to a particular user, the purging module will also
delete each complete form provided to the user, including
background or static data, such as header information, general
instructions, guidelines, disclaimers, consent statements, etc. In
various embodiments, the user will be assigned a unique
identification code that will correlate the user with the user's
consent forms. In some embodiments, the unique identification code
may be randomly generated and assigned, while in some embodiments,
the code may be based on an internal filing algorithm. In some
embodiments, all data is purged with the exception of the unique
user code.
[0073] In various embodiments, the computer readable instructions
on the mobile device may incorporate a timer to monitor the amount
of time the user has to complete the assigned forms and documents.
In some embodiments, the user may be given a limited amount of time
(603g) to compete the forms. The time may begin when the user
provides security credentials to the mobile device allowing access
to the assigned forms. In various embodiments, the timing device
may provide a countdown indicating the remaining time to complete
the forms. Additional exemplary embodiments provide that the timing
device may provide a warning to the user at various predetermined
intervals. For example, the user may be allotted 20 min to complete
the assigned forms and warnings may appear at 15 min remaining, 10
min remaining, 5 min remaining, 2 min remaining, and 1 min
remaining. The time notifications may be adjusted and may include a
combination of occasional "pop-up" notifications and an ongoing
countdown (e.g., pop-up notifications for the first 15 min and an
ongoing countdown for the last 5 min).
[0074] In various embodiments, computer readable instructions
provide that data is purged or deleted from the mobile device at
the conclusion of a user session. In an exemplary embodiment of the
purging algorithm, the user may select a "submit" button to signify
completion of the authorization process. Once the user submits the
completed forms to the central computing system, a notification
acknowledging receipt of the completed documents by the central
computing system may be sent to the mobile device. In one
embodiment, the user may be asked to manually confirm the end of
the session by, for example, responding to an "end session now?"
prompt. In another embodiment, the user may be provided with an
indication that the session will automatically end in a set amount
of time (e.g., 30 seconds). Upon completion of the session, one
embodiment provides that the user is provided notice that his or
her personal information will be permanently deleted from the
mobile device. In another embodiment, the user's personal
information may be deleted without notification to the user.
[0075] In yet another embodiment, the computer readable
instructions provide that data is purged if the allotted time for a
user session expires. Specifically, in various embodiments, a user
may be provided with a limited amount of time to read and provide
consent for the documents provided. In embodiments where a timing
module is employed, the purging module may be engaged if the user
fails to complete and submit the forms within the time period
provided. In some embodiments, when the timing module indicates
that time has expired, the user may be provided with a prompt that
may allow the user to extend the amount of time required to
complete the consent forms. For example, a user prompt may provide
"do you need more time?" or "are you still there?" in order to
assess whether the user is still actively interacting with the
mobile device. In an exemplary embodiment the user may be provided
with an additional amount of time in which to respond to the prompt
(e.g., 10 seconds). In an embodiment where the user is still
engaged with the mobile device, the user may indicate his or her
continued involvement and the timing module may be reset to allow
the user additional time (e.g., 10 minutes) to complete the consent
form process. In another embodiment, the user may fail to respond
to the prompt within a set amount of time or indicate that no
additional time is desired to complete the consent forms, thereby
ending the user session. In an embodiment where no response is
received within the set time or the user indicates that no
additional time is required, the purging module will be employed.
In some embodiments, notice of the purging process may be provided
via the mobile device while other embodiments may provide that no
notice is provided to the mobile device. In some embodiments the
purging process will begin after a period of time has elapsed
(e.g., 20 seconds) after the time to enter a response has expired
or after the user indicates that no additional time is required,
while other embodiments may provide that the purging process begins
immediately upon expiration of the time to enter a response or
immediately upon the receipt of the user indicating that no
additional time is required to complete forms. In some embodiments,
the user may manually end the session by submitting the forms upon
completion. In some embodiments the user manually ends the session
without completing the forms. In various embodiments, when the
session has ended, whether the session has timed out or was ended
manually, computer readable instructions provide that personal
information is purged or deleted from the mobile device.
[0076] In another embodiment the system may provide additional
security by limiting the range of the mobile device to a specified
distance (603h). Limiting the range of the device, for example by
restricting the transmission range of the network signal, may
protect personal data in the event the mobile device is stolen. In
an exemplary embodiment, the device is limited to the range of the
Wi-Fi connection. In the exemplary embodiment where the mobile
device is taken beyond the signal boundaries, the user may be
notified with for example with an alarm such as an audible
notification, or a visual notification such as warning message or a
visual flashing indicator. If the device is moved beyond the Wi-Fi
range, the computer readable instructions will provide that the
mobile device will automatically be cleared of all personal
data.
[0077] In some embodiments computer readable instructions provide
that the device is "locked" to prevent any use of the mobile device
if the mobile device loses connection with the network signal. In
an embodiment where the system is locked, it may be necessary to
reset the mobile device where the device is cleaned of all personal
information and is restored to a state such that no personal
information remains on the device. In one embodiment, a device that
is mistakenly removed beyond the preset limits will require that
the user forms be resent from the central computing system to the
mobile device.
[0078] In various embodiments, the mobile device includes a
tracking device, such as a Global Positioning System (GPS). In an
exemplary embodiment, if a mobile device is removed beyond a
predetermined range, the GPS system may be activated. Activation of
the GPS may allow for the proper recovery of the mobile device in
order to maintain mobile device inventory.
[0079] FIG. 7 provides in illustrative embodiment of a screen that
the user may be provided with to set or enter a password. In
various embodiments the screen is accessible via a web-interface
(701). In some embodiments the user login screen may be provided
through computer readable instructions such a software program with
a security module for allowing a user secure access. In various
embodiments, the user may first set a user identification and/or
password (702) using a login page. Upon entry, the user may be
prompted to "save" the login information (703). The saved user
login information can be associated with the user and/or the user
information stored in the user's electronic data file. In other
embodiments, the user will be presented with a login screen to
enter his or her stored, pre-set user identification and/or
password. The computer readable instructions may allow the user
access to the user's personal documents, such as consent forms upon
entry of a user identification and/or password that matches the
pre-set.
[0080] In one embodiment, multiple users may access personal
information simultaneously. The central computing system supports
pushing unique documents corresponding to a unique user to each of
multiple mobile devices. In this exemplary embodiment, multiple
users can access their personal documents on independent mobile
devices. For example, document set A, is transferred to mobile
device A, where user A can enter his or her unique password to
acknowledge and consent to documents. Similarly, document set B, is
transferred to mobile device B, where user B can enter his or her
unique password to acknowledge and consent to documents. In this
exemplary embodiment, document set A may contain 3 documents and
document set B may contain 5 documents requiring consent. Mobile
device A may be a tablet device and mobile device B may be a laptop
computing device. Password A may been assigned based on the device
whereas password B may have been preset by the user. Both user A
and user B may access document sets A and B, simultaneously from
devices A and B respectively.
[0081] FIG. 8 provides an exemplary embodiment of a method of
obtaining consent in a clinical environment. In this embodiment,
the user pre-registers for services prior to arriving onsite for
services. The pre-registration process may involve entering
information such as name, address and phone number in order to
establish a user profile. The pre-registration process may allow
the user to create a password for accessing account information in
the future. Additionally, the pre-registration process may request
that the user provide other information as deemed by the process to
expedite onsite registration. For one example, the pre-registration
process may allow the user to complete medical history documents or
provide information regarding the upcoming onsite visit.
[0082] In another embodiment, the user has not completed the
pre-registration process and the user is registered onsite. In some
embodiments, office staff may register the user or in other
embodiments the user may use computing systems onsite to register
himself. After completing the registration process, the appropriate
consent forms can be generated. The consent forms may be generated
based on the specific needs of the user. The forms that are
generated may be based on information provided during the user's
registration process, other information that may be available in a
user's history, or the particular reason for the office visit. For
example, in a medical treatment facility (e.g., hospital, clinic,
etc.), the generated consent forms may also include forms that
comply with any regulations for medical treatment (e.g., HIPPA
compliant documents).
[0083] In one embodiment a local hand held device is first
registered to a personal computer. In an alternative embodiment, as
shown in FIG. 8A, this step is not required.
[0084] In a particular embodiment, a mobile device is then assigned
to the user. The process of assigning the device to the user may
include computer logic that allows syncing the device to the
central computing system to enable a transfer of the customized
consent forms that the user is required to authorize. In other
embodiments, the user may have to set or enter a password, pin or
other personal identification that the user will have to use to
securely access customized forms via the mobile device.
[0085] In the exemplary embodiment, forms are then transmitted via
a secure digital connection to the user's mobile device. The user
may access the forms for review. In some embodiments, the user may
access the forms on the mobile device by entering a password, pin,
or other personal identification. In various embodiments, forms may
be provided via secure user email. In some embodiments, access to
forms is not provided via a user's personal email or other third
party account. The user may be provided with a single form to
provide consent or a plurality of forms for attestation of consent.
The user may read and provide answers to the forms as required.
Upon reaching the end of a form, the user affixes his or her
signature to the form. The user is then provided with an additional
form to review and consent until the user reaches the last document
in his or her queue of forms.
[0086] In various embodiments, the forms are completed when the
user affixes a signature to the form. The signature of attestation
of consent could be in the form of a handwritten signature using an
appropriate writing tool on a touch screen or the entry of a
personal authorization code or key to validate document. Once a
form has been completed and authorized, the next form in the user's
queue is made available for review and consent. Once all forms in
the queue have been completed, the completed documents are
submitted back to the central computing system. In an exemplary
embodiment, the record of the user's forms is purged from the
mobile device.
[0087] In one embodiment, upon completion of all forms, the user
transmits the completed forms back to the central computing system.
Upon submitting the forms, the files are then deleted from the
mobile device.
[0088] In an exemplary embodiment, the forms are available for
review by the office staff via the central computing device. In
another embodiment, the completed forms may be available for review
on another secure device, such as another secure computer or mobile
system, designated for reviewing completed documents by authorized
personnel. Upon review, the completed electronic forms may be
included in the user's secure electronic file. In some embodiments,
the completed forms may be purged from the computing system or
mobile device used for review after the form has been appropriately
filed. It will be apparent to those skilled in the art that various
modifications and variations can be made to various embodiments
described herein without departing from the spirit or scope of the
teachings herein. Thus, it is intended that various embodiments
cover other modifications and variations of various embodiments
within the scope of the present teachings.
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